Beste apotheek van Nederland

C-99
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Rosen (2006) 109
Funding
source: Bayer,
and
GlaxoSmithKline
N screened = 488
N randomized = 280
IG1, n = 137
CG, n = 143
ITT analysis used for
primary outcome: yes (also
LOCF)
Inclusion: men 18 or older
with ED for 6 mo or longer;
with diagnosed but
untreated mild major
depressive disorder; who
were not in psychotherapy
or taking antidepressants; in
a stable heterosexual
relationship for more than 6
mo with 50% or more failure
rate on at least 4 attempts of
sexual intercourse
Exclusion: men medically
unstable; hx of substance
abuse, serious suicidal or
homicidal risk, bipolar,
schizophrenia, delusional,
panic, or personality
disorder, posttraumatic
stress; penile anatomical
abnormalities, primary
hypoactive SD; SCI; or prior
non-response to sildenafil.
Age, mean (sd);
54 (10) vs. 52 (12)
Race, (%):
Caucasian 75;
Black 8; Asian 2;
Hispanic <1;
American Indian
<1
Co-morbidities:
NR
Previous ED
treatment, %:
Sidenafil 59
BMI, mean (sd):
28 (4) vs. 27 (4)
kg/m 2
Smoking status,
%: 51
Body weight
mean (sd): 85
(15) kg
(overweight)
Concomitant
medications: None
Duration of ED,
mean (sd): >6mo
3.5 (4)
Underlying
disease, %:
Depression 100; DM
15; vvascular
hypertensive 29;
elevated cholesterol
12
Psychogenic ED, n
(%); 32 (24) vs. 49
(37)
Physiologic ED: 25
(19) vs. 15 (11)
Mixed ED, n (%):
75 (57) vs. 69 (52)
Other, n (%): 12%
with elevated
cholesterol
IG: Vardenafil
CG: Placebo
IG1:
Dose: 10 mg (titrated to
5 or 20 mg at 4, or 8
wks)
Duration: 12 wks
Frequency: once/d
Compliance, n (%): 118
(86)
CG:
Dose: NA (titration as
IG)
Duration: 12 wks
Frequency: Once/d
Compliance n, (%): 111
(78)
Run In period: 4wk
Wash out period:
None
F/u duration (on and
off treatment): wk 4, 8
12
Primary outcome results:
IIEF Score, least square mean (LSM):
IIEF-EF LS mean improved from
baseline: 10 vs. 2, p<0.0001
Intercourse satisfaction: 10.9 vs. 7.8
OF: 7.7 vs. 5.9
OS: 7.1 vs. 4.9
SD: 7.3 vs. 6.4
Erectile hardness: 55.2 vs. 25
SEP-Q2: 76.7 vs. 52.4, p<0.0001
SEP-3: 66.4 vs. 38.1, p<0.0001
GAQ, % improved: (LOCF): 83% vs.
30%; p<0.0001
Other outcomes assessed: Remission
of depressive symptoms
Withdrawals/drop-outs/loss to f/u, n
(%): 10 (7) vs. 29(20); including
Insufficient therapeutic effect: 2 (1) vs.
10 (7)
WDAE, n (%): 4 (3) vs. 2 (1); reason
NR
TAE, n (%): NR; AE in at least 2% of
pts included headache: 15 (11) vs. 1
(1); flushing: 9 (7) vs. 1 (1); nasal
congestion: 4 (3) vs. 0; insomnia: 0 vs.
4 (3)
SAE: NR (no death occurred)
Outcome ascertainment: IIEF
domains, SEP-2/3;GAQ; Hamilton
Depression rating scale (HAM-D) score,
Rosenberg self-esteem scale.